Boehringer Ingelheim, Ingelheim, Germany, sponsored this study and provided funding for the conduct, data analysis, and medical writing assistance for the study’s publication, and for the journal’s Rapid Service fee.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
David Hall, PhD, contributed to analysis of the data. The authors would like to thank the following Principal Investigators involved with this trial: Dr Afsaneh Alavi, Dr Asunción Ballester, Prof Luca Bianchi, Dr Pablo de la Cueva, Dr Sascha Gerdes, Prof Lars Iversen, Dr Natalia Kuzmina, Dr Amra Osmancevic, Dr Sandra Philipp, Dr Luis Puig, Prof Franco Rongioletti, Prof Lone Skov, Prof Simon Francis Thomsen, and Dr Irina Turchin. Agreements between Boehringer Ingelheim and the authors included confidentiality of the study data. All authors collaborated on the writing of the manuscript. We thank all patients who participated in this clinical study.
Medical Writing and Editorial Assistance
Editorial assistance in the preparation of this article was provided by Amy Pashler, PhD, and Leigh Church, PhD, of OPEN Health Communications (London, UK) and funded by Boehringer Ingelheim.
This manuscript is based on work that was previously presented at the 119th Annual Meeting of the Japanese Dermatological Association, June 4–7, 2020, Kyoto, Japan.
Ulrich Mrowietz has served as an advisor/received speaker’s honoraria/received grants from/investigator for AbbVie, Almirall, Aristea, Boehringer Ingelheim (BI), Celgene, Dr. Reddy’s Laboratories, Eli Lilly, Foamix, Formycon, Forward Pharma, Janssen, LEO Pharma, medac, Novartis, Union Chimique Belge (UCB), and XenoPort. A. David Burden has served as an advisor/received speaker’s honoraria/grants/investigator for AbbVie, Almirall, BI, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, and UCB. Robert Bissonnette is an advisory board member, consultant, speaker, investigator for/received honoraria/grants from, AbbVie, Almirall, AnaptysBio, Arcutis, Aristea, Bausch Health/Valeant, BI, Boston Pharma, Bristol Myers Squibb (BMS), Dermavant, Eli Lilly, Escalier, Janssen, Kineta, Kyowa Kirin, LEO Pharma, Pfizer, Regeneron, Sienna, and UCB. Robert Bissonnette is also an employee and shareholder of Innovaderm Research. Kristian Reich has served as an advisor/speaker for/investigator for AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, BI, BMS, Celgene, Janssen Biotech Covagen, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline (GSK), Janssen-Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, medac, Merck Sharp & Dohme (MSD), Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and XenoPort. Andreas Pinter has served as an advisor/speaker/received grants from/investigator for AbbVie, Almirall Hermal, Amgen, Biogen Idec, BI, Celgene, GSK, Eli Lilly, Galderma, Hexal AG, Janssen, LEO Pharma, MC2, medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi Genzyme, Schering-Plough, and UCB. Knut Schäkel has served as an advisor/speaker/received grants from/investigator for AbbVie, Amgen, Almirall, Biogen, BI, BMS, Celgene, Chugai, Galderma, Janssen-Cilag, LEO Pharma, Lilly, MSD, Miltenyi Biotec, MorphoSys, Novartis, Pfizer, Polichem, Regeneron, and UCB. Yakov Datsenko, Hongjie Deng, Patrick Baum, Steven J Padula, and Christian Thoma are employed by BI.
Compliance with Ethics Guidelines
The clinical trial protocol, patient information leaflet, informed consent form, and other locally required documents were reviewed and approved by the Independent Ethics Committees and/or Institutional Review Boards of participating centers (master committee: Ethikkommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel, Germany). The study was conducted in compliance with the clinical trial protocol, in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and other applicable regulatory requirements and Boehringer Ingelheim’s standard operating procedures. Written informed consent was obtained from all patients prior to study initiation.
To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to all relevant material, including participant-level clinical study data, and relevant material as needed by them to fulfill their role and obligations as authors under the ICMJE criteria. Furthermore, clinical study documents (e.g., study report, study protocol, statistical analysis plan) and participant clinical study data are available to be shared after publication of the primary manuscript in a peer-reviewed journal and if regulatory activities are complete and other criteria met per the BI Policy on Transparency and Publication of Clinical Study Data: https://trials.boehringer-ingelheim.com/transparency_policy.html. Prior to providing access, documents will be examined, and, if necessary, redacted with data deidentified, to protect the personal data of study patients and personnel, and to respect the boundaries of the informed consent of the study patients. Clinical study reports and related clinical documents can be requested via this link: https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html.All such requests will be governed by a document sharing agreement. Bona fide, qualified scientific and medical researchers may request access to deidentified, analyzable participant clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a data sharing agreement, data are shared in a secured data access system for a limited period of 1 year, which may be extended upon request. Researchers should use https://clinicalstudydatarequest.com to request access to study data.